Stereotaxis, Inc.

Will you stand by? We're about to begin. Good morning. Thank you for joining us for Stereo Tax's fourth quarter and full year 2020 earnings conference call. Certain statements during the conference call and question and answer period to follow may relate to future events, expectations, and as such constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements involve known and unknown risks, uncertainties, and other factors which may cause the actual results, performance, or achievements of the company in the future to be materially different from the statements that the company's executives make today. These risks are described in detail in our public filings with the Securities and Exchange Commission, including our latest periodic report on Form 10-K or 10-Q. We assume no duty to update these statements. At this time, all participants have been placed on a listen-only mode. The floor will be open for questions and comments following the presentation. As a reminder, today's call is being recorded. It is now my pleasure to turn the floor over to your host, David Fischel, Chairman and CEO of Stereo Taxes.

Thank you, Operator, and good morning, everyone. I'm joined today by Kim Perry, our Chief Financial Officer. My prepared remarks today will be a bit longer than normal. I want to use the occasion of this being our annual call to provide a broader overview of Stereotaxis and our vision. I'll then review our accomplishments in 2020 and our focus and expectations for 2021. Stereotaxis is the global pioneer and leader of robotics for endovascular surgery. We have developed a highly innovative suite of robotic technologies that address the inherent limitations, risks, and challenges posed by manual catheters. Our mission is to make minimally invasive endovascular surgery broadly available to improve its safety and outcomes and to modernize it with the benefits of digitization and robotics. Endovascular surgery is a broad class of procedures where a catheter is inserted into a blood vessel and navigated through the vascular system to an area requiring therapy. While millions of catheter-based surgeries are performed annually to treat a wide variety of conditions, the mechanism of action of manual handheld catheters has fundamental flaws. During a procedure, therapy takes place at the catheter tip, but a manual catheter is held and manipulated several feet away at the handle. Using a manual catheter is like writing in small font while holding a pencil from its eraser or holding onto a gardening hose several feet back from its end. The mechanism leads to limited precision, limited stability, and limited reach. Manual catheters need to be rigid to allow for control to reach the tip, increasing the risk of patient injury. Procedures are complex and operator-dependent, and visualization of a catheter exposes patients' and physicians' x-ray radiation. Theriotaxis' robotic platform is designed to address these inherent limitations, risks, and challenges. It fundamentally transforms and improves catheter navigation by allowing for direct control of the catheter tip using precise computer-controlled magnetic fields. The magnetic fields can be viewed as invisible fingers holding onto the catheter tip. Direct control leads to , enables reaching areas previously unreachable, and enhances patient safety. Physicians operate with our robot from a computer cockpit, seated and fully protected from radiation, with full control over the procedure at their fingertips and with an ability to focus on the cognitive aspects of their profession rather than the mechanical efforts. Our technology is a platform technology, and the benefits of robotic precision and safety are applicable across a broad spectrum of endovascular and endoluminal procedures. We've begun efforts to address several new clinical applications, But to date, our primary focus has been on one specific endovascular procedure, cardiac ablation for the treatment of heart arrhythmias. Cardiac ablation has become a widely accepted therapy with over 1 million procedures performed annually and over $5 billion in annual medical device sales. The benefits of robotic magnetic navigation, precision, stability, reach, and safety are pronounced in cardiac ablation procedures and have been extensively validated. Hundreds of physicians at over 100 leading hospitals have treated over 100,000 patients with our technology, and there are over 400 scientific publications documenting our clinical value. A highly differentiated technology that confers meaningful clinical value to patients and physicians in a large field of medicine serves as the perfect foundation on which to build a preeminent medical robotics company. I have full confidence that Stereotaxis' magnetic mechanism of action, is the best way to treat patients and to address the inherent limitations and risks of manual endovascular surgery. Our vision is to positively transform endovascular surgery with robotics in a similar fashion to how intuitive surgical transforms laparoscopic surgery. To realize that vision, we have spent the last four years rehabilitating stereotaxis from its previous missteps, planting the seeds and nurturing the green shoots that will lead to a significant long-term growth. Our rebuilding efforts can be viewed within three broad categories, establishing financial strength, implementing the right commercial capabilities, and advancing a strategic innovation plan. 2020 was a year of significant progress on each of these fronts. Financially, Stereotaxis starts this year in the strongest financial position of its history, with $44 million in cash and no debt. Despite significant macro challenges last year and their negative impact, we have been able to operate at essentially break-even, with cash use of $1.2 million. This financial prudence is not at the expense of progress, and we continue to invest meaningfully in the drivers of long-term growth in our team and in our infrastructure. Commercially, Stereo Texas' primary focus has been on developing the infrastructure and processes that ensure existing robotic practices are successful, can grow, and can showcase their critical leadership in their communities. His focus on the success of existing robotic practices may not be the quickest way to add new customers, but it is the best strategy for increasing adoption of robotics and enhancing long-term business value. We view this as a multifaceted effort and have given various examples on previous calls of some of the key components. A few highlights of 2020 include the broad deployment of telerobotic support, allowing our clinical team to support procedures remotely. We are supporting multiple procedures daily around the globe with this differentiated capability and view our leadership as a strategic strength that will become increasingly valuable as remote support and collaboration in the operating room gains broader acceptance. The Robotic Electrophysiology Fellows Program continues to grow and plays a central role in ensuring the future leaders of our field are confident in our technology and its clinical value. 17 fellows successfully graduated from our program in 2020, and 21 new fellows enrolled in the program. The quantity and quality of clinical literature on our technology also continues to grow, with 31 peer-reviewed publications in 2020. Several publications last year were particularly interesting. including a case study on the treatment of a COVID-19 patient in ventricular storm, a review of over 1,000 patients treated at a single institution with outstanding efficacy and safety results, and the first use of our technology to treat pulmonary hypertension patients in a prospective randomized trial. We're already aware of additional impactful publications in queue for this coming year and look forward to sharing when available. We will continue to focus our commercial efforts on ensuring existing robotic practices are successful, but with the FDA approval of Genesis, we began incrementally investing, experimenting, and establishing capabilities that will allow for a robust capital sales pipeline. We are building this capability in a methodical fashion along with the buildup of our supply chain and in a way that is prudent, sustainable, and can support significant growth in capital sales over many years. In 2020, we were proud to sell and successfully install the first two Genesis systems at Helsinki University in Finland and Banner University in Arizona. Our Genesis system is performing to the highest expectations of our customers. Both sites are highly active, and the Genesis system was showcased in live broadcast procedures from both sites in December. On our last call, we provided preliminary guidance for 2021 of $10 to $20 million in robotic system sales. We are pleased with our momentum to date in meeting that guidance. We have five capital orders outstanding for robotic systems, four of which were generated in the period since our last call. The makeup of those orders are particularly interesting and reflect the initial green shoots of a broad-based global resurgence in interest in our robotic technology. Two of the orders are for genesis systems from US hospitals, one in the southeast and one in the west. Both hospitals are establishing entirely new robotic electrophysiology programs, and adoption of our technology is being championed by physicians that have no prior experience with robotics. Two of the orders are for Genesis systems in Europe. One, a replacement system for an aging Niobe, and the second is, again, a Greenfield system, which will represent the first robotic electrophysiology system in its country. Each of these systems have been ordered along with Stereotaxis' Model S imaging system. The fifth order is a Niobe system sold to a Greenfield customer in China, a country where we are seeing increasing interest in our technology despite Genesis lacking regulatory clearance. We expect all of these systems to be installed and recognized as revenue this year. We are excited by our initial momentum, but want to temper that enthusiasm with a reminder that the macro environment remains challenging for capital equipment and there's pronounced pressure from hospitals to delay lab replacement projects. We continue to see significant interest in Genesis, but the timing of any individual order remains difficult to predict. Genesis Stimulating a return to robust system sales reflects the first wave of revenue growth outlined in our strategic innovation plan. We have previously described two subsequent waves of revenue growth driven by strategic innovations. The first of these being a significant increase in disposable revenue with the launch of a proprietary ablation catheter, and the next being a set of innovations that will expand our technology into additional clinical applications. We are pleased with the significant progress we have had on both of these subsequent waves and how the three waves of revenue growth are poised to follow each other in relatively quick succession. SerioTexas' advanced robotically navigated magnetic ablation catheter has been advancing methodically through the establishment of a robust manufacturing process and bench and preclinical testing of that process. We are preparing production of hundreds of catheters to enable formal validation studies at the start of the second quarter and regulatory submissions for CE-MARC and an FDA IDE trial in summer. Concurrent with those efforts, we are progressing clinical, regulatory, and an EU commercialization plan. We have had initial discussions with regulators in both Europe and the U.S. and continue to expect EU commercialization and initiation of a pivotal U.S. trial in 2021. Given the feedback we received from physicians that have navigated our catheter in animal studies or in phantoms, we are excited and confident that the catheter will prove to be a significant improvement in clinical care and the physician experience. We are proud of our robust investment in innovation and the impact that innovation will have on patients, on our customers, and on stereotaxis. We are also cognizant that all of our technologies can be improved further. And our third wave of innovation is designed to be the most impactful to our revenue growth, both within electrophysiology and in expanding our robotic technology into several multi-billion dollar adjacent markets. We've been spending significant effort on this third wave and expect to be in a position to showcase key aspects of this third wave at the end of this year. Kim will now provide some commentary on our financial results, and then I'll make a few final comments before opening the line to Q&A.

Thanks, David, and good morning, everyone. Revenue for the fourth quarter of 2020 totaled 6.8 million, consistent with the prior year fourth quarter. Recurring revenue for the quarter was 5.9 million, and system revenue was 0.7 million. Revenue for the full year 2020 totaled 26.6 million. Recurring revenue of 22 million for the full year 2020 declined 15% from the prior year, primarily due to the impact of the COVID-19 pandemic on procedure volumes. We continue to see a gradual recovery in procedure levels from the lows reached in the second quarter of 2020, but volume remains below pre-pandemic levels. System revenue of $3.6 million for the full year 2020 increased from $2.1 million in the prior year, reflecting the successful installation of our initial Genesis RMN system. Gross margin for the fourth quarter and full year 2020 were approximately 77% and 71% of revenue. Operating expenses in the fourth quarter were $6.4 million, consistent with the $6.3 million in the prior year quarter. Operating expenses for the full year 2020 told $25.7 million, down from $27.6 million in 2019. Operating loss and net loss in the fourth quarter were both $1.2 million. For the full year, operating loss was $6.7 million with a net loss of $6.6 million. Negative pre-cash flow for the full year 2020 was $3.3 million and including funding from the payroll protection program was $1.2 million compared to $4.6 million for the full year 2019. At December 31st, we had cash and cash equivalents of $44.2 million. I will now hand the call back to David.

Thank you, Kim. Despite the significant operational and commercial challenges thrust upon us in 2020, the year was one of significant progress. We have a clear strategy for transforming endovascular medicine with robotics, and I'm proud of the way our team responded with resilience, prudence, and creativity to advance that strategy. 2021 is expected to be the start of a multi-year period of growth, and we reiterate our guidance of robust double-digit revenue growth in 2021, with Genesis system revenue of between $10 to $20 million. We continue to invest in the team, infrastructure, and projects that are critical for success, but are proud that we are able to do so while maintaining financial discipline. A robust balance sheet allows us to reach profitability without the need for additional financings. We look forward to now taking your questions. Operator, can you please open the line to Q&A?

Certainly, thank you. To signal for a question, please press star one on your telephone keypad. Also, if you are using a speakerphone, please make sure that your mute function is turned off to allow your signal to reach our equipment. Once again, it is star one at this time for questions. And we'll take our first question, and that will come from Josh Jennings with Catwin.

Good morning. Thanks, David and Kim. Congratulations on stoking up demand for Genesis and the strong order number. I wanted to ask, just the five orders since your last earnings call that crushed, beat our expectations clearly. I wanted to ask about the sales funnel. We don't want to get carried away and then take that five order number that you just delivered and and extrapolated throughout the rest of 2021. And I know you're not providing order guidance, but I was hoping you could give us a sense of the sales funnel. When we think about the pandemic in 2020, the Genesis launch, you know, just pushed out to 2021, have you? And I wanted to ask about the sales funnel in 21 here versus where it was in 2020 and just thinking about launch dynamics. I mean, our sense is that The demand funnel is exponentially higher. I mean, a multiple higher in size than where it was at this time last year. All the virtual visits that you were able to execute throughout the pandemic and ongoing into the third and fourth quarter. I'm sorry for the long-winded question, but really just to get to it, I wanted to comment on the sales funnel this year, where it stands versus where you were last year.

Sure. Thanks a lot, Josh. And so I think you're right that we don't want, we feel it's still premature to kind of every subsequent quarter. We're still in the early stages of our launch, and so we want to have a little bit of conservatism and caution on just kind of extrapolating numbers out. Overall, there's multiple hospitals that we're talking with, both Greenfield and replacement cycle hospitals that are in various stages of the pipeline. We're still early in our history of having capital sales, given that really for many years, stereotypes have not had a robust capital sales effort at all. And so it's still kind of we are in our own learning mode of trying to be able to understand when a hospital is at a specific stage in a process. what's the probabilities that they will move to the next stage. We just don't have enough numbers yet. So I hope that, you know, over the coming quarters, uh, we'll become smarter there and we'll be able to start giving kind of statistics. Um, uh, but we're still kind of a young company in that whole effort. So again, it, it kind of, it blends to a desire to be conservative. Um, uh on the replacement side if you kind of remember from my prepared remarks i mentioned that we are seeing many of those still being delayed out and so while historically we've talked about about a 15 million dollar a year replacement cycle and revenue that would be a very very easy to rely on i still very firmly believe that that's real. We don't see replacement cycles kind of slipping away from us, but we just see those being pushed out. I think given the macro environment, I think hospitals are trying to push out anything that they don't have to replace. And so that's being pushed out, and I would expect generally very little replacement cycle revenue this year. And then hopefully we get a bolus of that next year, some of the pent-up ones that have been delayed several years. There are multiple ones in discussions for next year. And so I guess kind of that's how we're looking at things. I would expect kind of a steady pace of system orders to continue coming in, but I don't necessarily want to extrapolate from one quarter out to the future ones.

That helps. Thanks, David. Just a follow-up on... just genesis utilization trends. I know there's only a couple installs out there, but I was hoping to get a sense of, in these early days, the utilization levels of genesis at centers with the elimination of latency, reduction of latency. In our higher percentage of genesis cases or for genesis centers that are using genesis in a population cases, you expect genesis to drive deeper penetration in AFib ablation versus VT or other arrhythmia indications?

So I think on our last call, we talked procedures having been performed at the first two hospitals since their installation. And I looked it up before this call, and it was still a little bit under 200. It would have been nice if it was 200 or more. We would have kind of called it out, but it was a little bit under 200. And so the utilization is definitely higher at those two sites than our typical average. Again, it's two hospitals. There are various circumstances that can lead to that higher utilization of which Genesis is one of them. But I don't want to yet with kind of small numbers to create kind of expectations there that every Genesis launch is going to necessarily be at a higher level. And we're being used at both sites for the broad range of arrhythmias, you know, from what are generally considered the simpler ones to the most complex.

Great. This is my last question. Thanks for taking all of them. I may be getting a little ahead of myself with the Genesis launch in the very early stages, first standing, if you will, with the TESA-like CEO compensation agreement that was announced yesterday. It implies or just confirms that you believe in robotic navigation as a platform technology and a long runway. Some of those milestones, $1 billion, $5.5 billion valuations, that set off triggers in your compensation plan. I wanted to just do a direct question is can you talk about how Genesys evolves from its current form and then just anything high level in terms of I know you had some comments here in your scripted remarks about being a platform technology and moving out of just the EP indication, but just the genesis technology as a whole, and then the indication progression, any updates there? Thanks for taking the questions, too.

Sure, thanks. So, yeah, in terms of the compensation plan, I think it reflects the fact that we are looking to build a long-term, very robust company that has a significant positive impact in medicine and very much want to create the right alignment of interests to build that long-term, highly impactful company. And when we think about kind of genesis, really the role of genesis as a medical device is to create very precise, uniform magnetic fields that are controlled by a physician where the patient's chest is or wherever the patient's anatomy is that requires therapy. And what you need to move to other indications is the right interventional devices that can be controlled by those magnetic fields. And right now, there's a cardiac ablation catheter that has the right kind of design so that it can be controlled by those magnetic fields. And in the future, you'll need a family of other devices to be able to do so. Again, I think there's kind of every aspect of our technology can be improved significantly from where it is. But kind of in order to move into other clinical applications, It's that kind of suite of interventional devices that needs to be developed.

Excellent. Congrats again. Thank you.

Moving on, we'll go to Frank Tekenen with Lake Street Capital Markets.

Hey, thanks for taking my questions, and congrats on a good quarter. First one from me is on the five purchase orders. curious if you could talk a little bit more to the cadence of those installs potentially in 2021. Maybe if you could help us at first half versus second half, just to get a little better understanding of the sales cycle from purchase order to install would be fantastic.

Sure. I would expect, we've already shipped the first of those, and I would expect that that those installs all take place roughly in the second quarter or summertime.

Okay, great.

Then moving on to the catheters, speaking about that a little bit, could you talk to some of the milestones we should be looking for throughout the next couple quarters to ensure we're on track for the EU launch in the second half or the back half of this year as well as the U.S. pivotal? And then maybe speak to the commercialization strategy and how that can change over the next couple of years with the launch of the catheter.

Sure. So on the catheter side, and we've been going through a very, very intensive cycle of receiving batches of catheters, evaluating those batches to ensure that not just one catheter or a few catheters, but all catheters in a batch are performing according to specifications kind of across a wide range of things that you test. And they continue to perform well despite some use, kind of some use and abuse. And then based on those learnings, you refine the manufacturing process to kind of to fix any areas or improve any aspects that kind of need improvement. And then you do another batch and you run the same cycle again. And so we've been running through that process multiple times now. And we're kind of getting to the point where now we're starting the manufacturing of hundreds of catheters to do formal testings. that gets submitted to regulators. And so the real kind of next steps are running those formal testing and having hopefully successful results, obviously, as we expect successful results from those testings, submitting that dossier that includes that testing to the EU notified body, and submitting an IDE application, which also rests on all of that testing to the FDA. And so kind of what you should see is kind of the next steps is us kind of completing that testing successfully and making submissions both in Europe and the U.S., and then receiving responses from both the European regulators and the FDA. And that's really kind of the next steps in the process. While we've been doing that, we have been obviously having discussions with the regulators in both geographies, and we've been planning for the commercialization in Europe. And so we are and making very detailed business plans for every individual existing customer in Europe about what the dynamics are in order to launch a catheter in that hospital, whether there are kind of tenders that are necessary or what kind of purchasing processes take place at the hospital. what the kind of drivers might be for adoption, how pricing should look like. And so we're very much planning for that launch kind of concurrent with all of these activities.

Perfect. And this last one for me, you guys have shown really good operating expense control this year. How should we think about operating expenses in fiscal year 21 as revenues grow? Yeah.

We want to continue investing in the business. There's a lot of exciting things on the R&D side still to advance the technology further. And I think, again, we're still just in the earliest innings of what's possible with robotic magnetic navigation, both in EP and obviously in many other clinical applications. And so there's a lot kind of that we can invest in, and we will continue to build up the team and to invest in meaningful projects that drive long-term growth. Also on the commercial side, We are making efforts to really try to modernize across the in-house team and the field team various aspects of our commercial infrastructure, and we will be growing the team in the coming quarters. And so I think what you should expect is a gradual increase in operating expenses while still maintaining financial prudence. And so we should never have a burn rate where some of you have concerns about us needing to raise capital or having any viability concerns, the fact that we have a very prudent business and a strong balance sheet, I think it's great for our customers. It's great for existing partners and potential partners. And it's just kind of I think that's the right way to run the business.

Perfect. Thanks, and congrats again. Thanks a lot.

Next, we'll go to Jason with Northland.

Hi, thanks for taking the questions. First off, you mentioned a China sale that you think will clear this year. Does that require an approval from the government, et cetera, or what's required on the regulatory front to get that installed and revenue recognized?

Hi, Jason. Good morning. So the sale to China was actually of the Niobe system. So because Genesis is not cleared in China, it was a sale of our Niobe system, which has regulatory clearance in China.

I see. Okay, that clarifies it. Also, can you kind of give some color in terms of how you're interacting with your partners, notably Acutis, which I believe you're partnered with? Are they helping with referrals or how is that relationship working in terms of promoting the system?

So at its core, we're great partners together because they have an elegant diagnostic technology and we have a very elegant robotic technology that navigates the therapeutic ablation catheter. And so we're delighted with our collaboration. We've started to see more and more hospitals use us together. We are seeing the initial use even this week of their context mapping capability with our system. And so there's a positive kind of collaboration there and a natural benefit of seeing our two technologies used together. try to support each other, but that's kind of not a big driver to the revenue growth. I think it's a broader aspect of our collaboration and the nice use of our technologies together, which is really the positive effect.

Okay, that makes sense. In terms of, you mentioned that these systems, it sounds like there's about There's a pretty wide range in terms of when these systems get installed, but it sounds like you're saying most of these are installed this summer. Did I hear that correctly in terms of the five orders that you received this quarter? So that would roughly imply a six-month time to installation. Maybe this has been asked before, but how should we think about this? It sounds like given that's the timeline, you know, by year, you know, basically anything that you haven't had by the summer basically falls into next year for revenues. Is that the right way to think about it?

I think generally the timeline will range anywhere from three months to 12 months or so. And so some of these orders will be installed in the second quarter. Some will be in the third quarter. It's somewhat dependent on the hospital itself. So we don't have full control over the installation timeline. It's the has its room ready for us and we can come in. But roughly, I think that three to 12-month timeline is right. And what you see based on kind of the orders that we're talking about now, it ends up generally, it doesn't seem like any of these five will be 12-month timelines. It seems like it will more be in the six-month or sub-six-month timeline.

Okay. And then on the catheter, I appreciated the update. Will you be ready to launch once you obtain CEMARC or will there be some delay for manufacturing once you get it?

We should be able to launch when we have CEMARC.

Okay. Well, thank you very much. Good quarter.

Appreciate it. Thanks, Jason.

And once again, it is star one at this time for questions. We'll pause to give everyone the opportunity to signal. We'll take our next question from Christopher Hillary with Rubuck Capital.

Hi, good morning.

Hi, good morning.

I wanted to ask, just given the strong demand that you've been able to see, are there some things that you've been able to learn from your kind of virtual sales process? Are there metrics that you're able to gather that maybe would have been harder to see from in person? And then also, does this change at all how you expect to kind of go to market as the economy reopens?

Great question. I'd say from a metrics perspective, again, the numbers of orders and the numbers of customers is still, we're still in a relatively small and in an early stage. And it's very hard to have statistics that you build modeling off of and that you can really rely on the probabilities. But in terms of these virtual test drives, telerobotic test drives that we've been performing, by now we've had over 300 physicians, hospital administrators, on these types of calls. And that has been an amazing, amazing experience for us and has allowed us to reach more of our existing customers and more potential customers than ever before. I'm hosting two physicians today, one from Europe, one from the US on such calls after this earnings call. And the ability to do that kind of without the disruptions of travel and kind of to do it in a very nice fashion has really been one of the big positives from last year. And that's something that I think we'll maintain long after the COVID restrictions disappear. And so that does impact some of how we're thinking about commercialization. I think you can build a commercial team very much like all other medical device companies where you hire people, you give them territories, And that's a fair model. That's something that we will do, that type of building. But we also won't build our commercial capability fully in just that way. If you look at some of the best companies out there, the Apples, the Teslas of the world, many of them have built great strength by having direct connections between the corporation and the customer. and making sure that that connection is a strong and very kind of customer-friendly connection. And so I think you'll see that we're going to do something, and we are doing kind of similar types of things. There's a lot of work still to do there. There's a lot of ways to make that better. But I think that you can also build a medical device company that doesn't necessarily have to rely purely on the old model of commercial teams. And so it will be a hybrid of those two approaches. And something like these tele-robotic test drives is much more in the latter model than the former.

Okay, great. Yeah, and I'm sure we'll all look forward to that year and update on the new products and expansions that you see. Thanks so much. Thank you.

Next, we'll go to Chris Basto, private investor.

Hey, David. How are you? Hi, Chris. Good morning.

Good morning. Congrats on the quarter and the guidance moving forward. Just had a question. With respect to some of your robotic peers, you know, learning about five orders on the call is great. Some of the previous or companies that are out there will announce the order on via press release when they get it. Are you still going down the path of potentially announcing these via press releases once they're installed? Or how do you think about how the shareholder base will learn about these new orders?

We will make press release announcements in coordination with our hospital customers, and we want to use those also to the benefit of the hospitals in their regions. so that they can showcase their leadership to their stakeholders. And so generally, I would expect for these quarterly earnings calls to be the primary source of hearing new orders. But there's no reason for you not to know the names of the hospitals that have ordered the system that we described today. Just those will happen in coordination with the local hospitals.

Okay, great.

And then you've talked about this expansion into multi-billion dollar adjacent markets where we're going to learn more later this year. I know you've been tight to the vest on this with respect to divulging information, but if I could ask, on the regulatory requirement front, what's the picture? What's the outlook as you move into these new adjacent markets? Is that going to require new filings across the board or what's Once you announce something, can you go there immediately? Can you give some color on that?

Yeah, there will be. I mean, whenever you develop new technologies, there is a regulatory process. And so I would expect us to have a regulatory process. I don't necessarily think that you're going to have a PMA process for some of these. And so... And so, again, I think kind of at the end of this year, we'll be in a position to give you much more color on the various technological components of that third wave and kind of the timelines that we think. We wouldn't talk about it if it was years off from commercialization, but there will be also a regulatory aspect to the timelines.

Okay, great. Well, look forward to that future. Congrats on the compensation package. You should be commended for what you've done so far, not getting paid for it. And I hope you get the full 10% on the deal that was put forth.

Thank you very much. I will work very hard to get the full 10%. Thanks, David. Thank you.

And there are no further questions at this time. I'd like to turn it back to our presenters for any additional or closing comments.

Okay. Thank you very much for your continued support and interest in stereo taxes. We're excited for the year ahead of us and look forward to speaking again in a couple months. Thank you.

Thank you. And that does conclude today's conference. We'd like to thank you for your participation. You may now disconnect.